Note: Descriptions are shown in the official language in which they were submitted.
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SIGNAL DATA EXTRACTION METHOD AND APPARATUS
FIELD OF THE INVENTION
The current invention relates to the field of signal data extraction,
more specifically to an improved apparatus and method for extracting signal
information from a plurality of signals obtained by visual pathway testing.
BACKGROUND OF THE INVENTION
Early detection of disease is of utmost importance in improving the
odds of successful treatment. However, once a patient presents with disease
symptoms, often, the disease is somewhat advanced or established. In order
to truly discover a potential problem at earlier stages, asymptomatic patients
should be screened for early signs of disease.
Glaucoma and other ocular and nerve-related diseases are among
diseases that could potentially be detected at an early stage. There exists in
the art a variety of tests that are capable of detecting early onset of
glaucoma
and other diseases of the nervous system.
Pattern VEP is a well-known diagnostic aid in the detection of
glaucoma and other nerve-related diseases. In this test, a patient observes
reversing patterns displayed on a screen and such sensory stimulation of the
visual field causes Visually Evoked Potentials (VEPs). Electrodes placed on a
subject's scalp detect the VEPs.
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In diagnosing and/or screening patients using VEP techniques, a
clinician looks for an N75 P100 N135 complex in a resultant waveform. The
N75 P100 N135 complex conveys important information about the condition of
the nervous cells carrying a nerve impulse.
Pattern Electroretinography (PERG) is a diagnostic tool for ocular
disease that is similar to VEP. However, unlike with VEP where signal from
the visual cortex is captured at the back of the skull, with PERG signal is
collected directly from the retina by way of a sensor placed under the
patient's
eye. With PERG testing the diagnostically important waveform has an N35-
P50-N95 complex.
Typically, each time a pattern displayed on the screen is flipped, a
signal is generated. After a specified number of signals is captured, a
software program signal averages the plurality of captured signals and
produces one waveform which represents the N75 P100 N135 complex or the
N35-P50-N95 complex ¨ as the case may be.
One problem with this method of producing a signal-averaged
signal is that signals that do not correspond to the N75 P100 N135 complex or
to the N35-P50-N95 complex may be included in the signal-averaged
waveform. For example, signal artifacts caused by a patient blinking or
moving may be erroneously included into the signal-averaged waveform. As a
consequence, the sensitivity and specificity of the VEP or PERG test may be
diminished or compromised.
SUMMARY OF THE INVENTION
The present invention is directed to a novel method and apparatus for
enhancing the accuracy of a signal-averaged waveform that is derived from a
plurality of signals. The system identifies a time frame during which an area
of
interest is expected to occur in a signal ("area of interest" being either a
peak
or a trough). The system then examines a plurality of signals to determine if
the area of interest is present in respective ones of the plurality of
signals.
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Once the area of interest is detected in a respective number of signals during
the expected time frame ¨ then the area of interest is validated. For example,
if the area of interest is a peak and the expected time frame is between 90
and 120 milliseconds, then when a predetermined number of peaks (e.g. 5
peaks) or a predetermined percentage of peaks is detected in the timeframe
between 90 and 120 milliseconds ¨ the system will determine that it located
and validated the area of interest. Once such determination is made ¨ peaks
that occur outside of the given timeframe (i.e. earlier than 90 msec or later
than 120 msec) are disregarded.
The system, as such, identifies signals that are supportive of a waveform
of interest and those that are not supportive of a waveform of interest. The
signals that are not supportive of a waveform of interest are not included in
a
signal-averaged test result.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a schematic view of a system architecture according to an
embodiment of the invention.
Fig. 2 shows a low contrast checkerboard pattern according to an
embodiment of the invention.
Fig. 3 shows a high contrast checkerboard pattern according to an
embodiment of the invention.
Fig. 4 shows a read-out of two signal-averaged waveforms obtained
from a patient's right and left eye, respectively according to an embodiment
of
the invention.
Fig. 5 shows a read-out of a signal-averaged waveform obtained from
a patient during PERG testing according to an embodiment of the invention.
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DETAILED DESCRIPTION OF THE INVENTION
Embodiments of the present invention will now be described with reference to
the
above-identified Drawings. However, the Drawings and the description herein of
the
invention are not intended to limit the scope of the invention, it will be
understood that
various modifications of the present description of the invention are possible
, Also,
features described herein may be omitted, additional features may be included,
and/or
features described herein may be combined in a manner different from the
specific
cOrribiriations recited herein.
Referring to Fig. 1, a system configuration of the hardware
components according to an embodiment of the invention is shown. As
shown, a display device 102, or stimulus monitor is provided for displaying
patterns to a viewer 104. Sensors 10, 12 and 14, such as disposable
electrodes, attached non-invasively tc a patient's scalp or below the
patient's
eye detect responses to stimuli generated by the optic nerve or by the retina,
respectively. Such responses are amplited, digitized, recorded and analyzed
by tile data acquisition component 107. Conductors 116, 118 and 120 collect
information from sensors 10, 14 and 12 respectively, which are positioned on
the scalp of the patient 104 over the visual cortex, the frontal cortex, and
the
parietal cortex, respeOtively. Conductors 116, 118 and 120 are connected to
the VEP recording and measuring device. Conductor 121, is positioned
beneath the eye of a patient is connected to a PERG measuring device.
A VEP or PERG recording and measuring device (or data
acquisition component) 107, acquires responses to brain or retina sffmuli. The
data acquisition component comprises an amplifier 106, which reoeives
signals from sensors 116, 118, 120 and/or 121 and amplifies the VEP/PERG
signals. Such amplified signal is then supplied to an analog to digital
converter
108 for converting the anaiog VEP/PERG signals into digitai form. The data
acquisition component is connected to a central processing unit 110 of a
=
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computer for controlling the operations and functions of the VEP/PERG
recording and measuring device. The computer has and/or is connected to a
digital storage medium for storing signal data and other necessary
information. The CPU is connected to a Graphic User Interface (GUI) or
monitor 112, which displays data captured by the VEP/PERG recording and
measuring device and conveys information concerning the operation of a test
being conducted to an operator. Keyboard 114, connected to CPU 110, allows
for an operator to input information to the computer relating to a subject
being
tested. A printer 124 also connected to the CPU allows for test results to be
printed out. A visual stimulus-generating device 122 such as a video card is
also connected to the CPU and is controlled thereby. Stimulus generating
device 122 generates the patterns that are perceived by the patient on
monitor 102. Stimulus generating device 102 is connected to the data
acquisition component 107 by way of a Sync Card 126. The Sync Card 126,
synchronizes the periodic visual stimulus and the sampling rate for recording
the VEP/PERG signal responses. Software running on the computer is
programmed to carry out the processing steps described herein.
Figs 2 and 3 show two examples of patterns that are shown to a
patient in order to stimulate the retina and the optic pathway. Fig. 2 shows a
low contrast, checkerboard pattern, whereas Fig. 3 shows a high contrast
pattern. In either case, a "pattern flip" is perfromed by reversing the light
and
dark boxes on the checkerboard. It will be understood by one of ordinary skill
in the art that other patterns are possible and are within the scope of the
current invention.
In diagnosing and or screening patients using VEP techniques, the
N75-P100-N135 complex conveys important information about the condition
of the retina's ganglion cells and the optic nerve which carries the nerve
impulse. The N75-P100-N135 complex, which is well known in the art of VEP,
corresponds roughly to the depolarization and repolarization phases of an
action potential. Latency or diminished amplitudes of the N75-P100-N135
response may indicate nerve damage such as loss of conduction, for
example, due to a myelin sheath deficiency. It is thus, the N75-P100-N135
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complex that is the focus of VEP testing. Signal portions that are not
associated with the N75-P100-N135 complex are, for the most part,
diagnostically uninteresting.
As described, in order to include only signals that are supportive of the
N75 P100 N135 complex, the software is trained to disregard artifacts and
signals that are not representative of the N75 P100 N135 complex. In one
embodiment, the software is trained to analyze two or more frames at a time
and signal average them. An automatic cursor placement routine locates the
P100 peak for each signal-averaged pair of frames. The P100s are evaluated
using a histogram. A cluster found in the range of the expected P100 is
identified. If the cluster is comprised of a sufficient percentage of the
frames
from the entire test, then a P100 has been identified. Frames outside this
cluster are not included in the signal-averaged test result. This results in a
cleaner and more accurate VEP response ¨ as signal that is not supportive of
the P100 is not included in the resultant signal averaged waveform.
For example, given a specific contrast pattern, a P100 peak is
expected to occur roughly between 93 and 118 milliseconds. In such a testing
environment, the software is trained to generate a histogram or such similar
plotting function to identify a cluster of peaks that occur within 93 and 118
milliseconds. If a predetermined number of peaks are identified in the
expected time - then the software concludes that the P100 peak has been
located and validated. Any peaks that are outside of the expected time frame
are rejected and not included into the signal-averaged waveform. in one
embodiment of the invention, the expected timeframe for the P100 peak is in
a range from 80 to 140msec. It will be understood by those of ordinary skill
in
the art that any of various ranges are possible in different embodiments of
the
invention ¨ all of which are within the teaching of this invention.
In one embodiment of the invention, signal clusters located in two or
three (or more) consecutive bins are used to identify N75-P100 complex. Any
peaks that are located before or after the specified three (or more) bins are
recognized as outliers and they are therefore not included in the signal-
averaged waveform. It will be understood that the number of consecutive bins
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may vary ¨ and they can be more or less than three in different embodiments
of the invention.
If an insufficient number of frames are found in a cluster, then the P100
will not be identified. This is important because neural noise alone can tend
to create peaks that could be misinterpreted as a P100 response. What
results is a more stable P100 response since it is not as effected by random
frames which might would tend to shift the true P100 by more or less from test
to test.
It will be understood that the latency of a response may be obtained in
any of various ways in different embodiments of the invention. For example,
rather than examining single frames to detect P100 latencies ¨ the system
instead signal averages two or more frames of responses (each resulting from
a different stimulus) and it incorporates the latency of the signal averaged
waveform as one frame in the bin that has a corresponding latency range.
More specifically, assuming that a signal is generated each time a pattern is
flipped ¨ the system does not analyze each generated signal to detect P100
peaks ¨ rather the system creates composite signal-averaged waveforms and
it analyzes the signal-average waveforms to determine if a P100 peak is
present. When a cluster of signal-averaged P100 peaks is identified ¨ the
system concludes that the P100 has been located. It will be understood by
those of ordinary skill in the art that single frames may be analyzed for P100
peaks and it is not necessary to analyze composites of two or more frames. It
will be further understood that composites of more than two signals may
analyzed in different embodiments of the invention.
As described, the system identifies a cluster of P100 peaks in order to
conclude that the P100 has been located and validated. A cluster may be
established in any of various means. In one embodiment of the invention, the
system determines a ratio of valid signal to invalid signal and uses the ratio
to
determine if sufficient number of valid signals were obtained. If a sufficient
percentage of response signals is valid ¨ then a cluster has been established.
For example, if a waveform of interest contains a P100 peak arriving in the
timeframe between 80 to 140msec, then a signal having such peak within the
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given timeframe is a "valid signal." Peaks that fall outside of the 80 to
140msec timeframe are said to be "invalid." After all signals from a complete
test have been obtained and stored, the system determines what percentage
of signals is valid. If the percentage is above a predetermined percentage
value ¨ then a cluster of P100 peaks is established and the P100 is located
and validated. If the percentage of valid signals is below a predetermined
percentage, then a cluster is not established and the P100 is not validated.
In
an embodiment of the invention, the predetermined percentage value ranges
from 30-50% - but different ranges and different percentage values may be
used in different embodiments of the invention.
The software of the invention is programmed to carry out several
principal functions for each test. All signals derived from nerve stimuli are
stored on a digital storage medium. The software then analyzes the stored
signal data to determine if a cluster of signals have been obtained that are
supportive of a particular waveform (e.g. a P100 latency). The software then
takes two independent signals and signal averages them into a signal
averaged waveform. The signal-averaged waveform is then analyzed to
detect a P100 peak within a given time frame. The software continues this
process until all or a predetermined number of signals obtained is analyzed to
identify the P100 (or other area of interest). The software then calculates
the
number of signals in which the P100 was identified out of the total number of
signals obtained for a given test. The software then determines if the
percentage of signals in which the P100 was identified is above a
predetermined percentage value. If the number is above a predetermined
percentage value, then the software concludes that the P100 or other signal
area of interest is located and validated. The software then signal-averages
all
the signals in which the P100 was detected within the given timeframe to yield
a resultant signal-averaged waveform which represents the results of a test.
Any outlier signals are disregarded and not incorporated into the resultant
signal-averaged waveform.
As a result, the inventive system identifies frames that are not
supportive of the VEP N75 P100 complex, and removes them from the signal-
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averaged result. The resulting response has a number of benefits: a good
response whether with the expected P100 latency or delayed P100 latency
tends to be less noisy (making the P100 easier to identify), and the P100
latency tends to be more stable test after test. Poor responses (whether
caused by pathology or patient inattentiveness or poor patient connectivity)
can be identified as such, so that an erroneous P100 latency is not
calculated.
Fig. 4 shows two signal-averaged waveforms obtained from a
patient's right and left eye, respectively. A P100 peak is shown occurring
roughly between 85 and 120 msec (time frame B). In this example, a cluster
of peaks occurring in timeframe B are identified and included in a signal-
averaged waveform. Once a threshold number of signals are detected within
timeframe B ¨ a P100 peak is established. Any peak occurring outside of
timeframe B (i.e. timeframe A and C), is disregarded and is not included into
the final resultant signal-averaged waveform.
Pattern Electroretinography (PERG) is another diagnostic modality
used in the detection of glaucoma. PERG is similar to VEP in that signal is
generated by stimuli resulting from a patient observing pattern flipping on a
screen. However, the signal is captured by a specialized sensor that is placed
under the eye of a patient. In testing with PERG, the diagnostically important
waveform has an N35-P50-N95 complex. The N35-P50-N95 complex is
similar to the expected waveform for VEP except that it is typically smaller
in
amplitude, and shifted to the left in time. Because the PERG sensor receives
stimuli directly from the retina (in contrast to VEP which capture signal at
the
back of the skull), signal is captured earlier in time as compared to VEP and
as a result the N35-P50-N95 complex is shifted left. Consequently, while VEP
signal peaks at or around 100msec, PERG signal peaks at around 50msec.
In an embodiment of the invention, the system is programmed to
identify P50 peaks in a PERG signal. In a similar manner as described with
respect to VEP, a time frame during which the P50 is expected to occur is
identified. Once a predetermined number of peaks within the expected
timeframe is detected ¨ the software concludes that the P50 has been located
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and validated. For example, in one embodiment of the invention, the software
is set to identify peaks arriving between 40 and 60 milliseconds as P50 peaks.
Once a cluster of peaks is detected in that timeframe ¨ then the P50 is
located. Any peaks that arrive outside of the timeframe (i.e. earlier than 40
or
later than 60 msec) are disregarded and they are not included in the resultant
signal averaged waveform.
Fig. 5 shows a signal-averaged waveform obtained from a patient
during PERG testing. A P50 peak is shown occurring roughly between 48 and
52 msec (time frame E). In this example, a cluster of peaks occurring in
timeframe E are identified and included in a signal-averaged waveform. Once
a threshold number of signals are detected within timeframe E ¨ a P50 peak
is established and validated. Any peak occurring outside of timeframe B (i.e.
timeframe D and F), is disregarded and is not included into the signal-
averaged waveform that represents the test result.
It will be understood that the method and system described herein may
be used for any plurality of signals acquired in various testing environments
and VEP and PERG are exemplary only.
Having described this invention with regard to specific embodiments, it
is to be understood that the description is not meant as a limitation since
further modifications and variations may be apparent or may suggest
themselves to those skilled in the art. It is intended that the present
application cover all such modifications and variations.
